Clearance Summary
UFR DIGITAL RETROFIT received FDA 510(k) clearance under submission number K875312, sponsored by Yankee Intl. Medical Research & Mfg., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1988-02-19.
- Submission: K875312
- Applicant / Sponsor: Yankee Intl. Medical Research & Mfg., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1988-02-19
Classification & Regulation
This clearance is catalogued under FDA product code FJB and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.